E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results

Date: 02/18/2022

Product type: Medical Device

Product Names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade Name: E25Bio SARS-CoV-2 Antigen Test Kit

Product Codes and Model Numbers: See Recall Database Entry

Distribution Dates: September 2020 to November 2021

Devices Recalled in the U.S.: 73,300

Date Initiated by Firm: January 27, 2022

FDA-USA Link: https://www.fda.gov/medical-devices/medical-device-recalls/e25bio-recalls-covid-19-direct-antigen-rapid-tests-are-not-authorized-cleared-or-approved-fda-and